SINGLE DOSE ABLATIVE PREOPERATIVE RADIATION TREATMENT FOR EARLY-STAGE BREAST CANCER IN ELDERLY PATIENTS
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON54805
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
• Females at least 50 years of age, with an unifocal cT1N0M0 non-lobular breast
cancer on mammogram/ultrasound/MRI and sentinel node biopsy
• Females at least 70 years of age, with an unifocal cT1-2(maximum 3 cm)N0M0
non-lobular breast cancer on mammogram/ultrasound/MRI and sentinel node biopsy
• Tumor with negative Her2neu receptor and positive estogen receptor
• Adequate communication and understanding skills of the Dutch language
• Legal incapacity
• BRCA gene mutation.
• WHO performance scale > 2.
• Previous history of breast cancer
• Other type of malignancy within 5 years before breast cancer diagnosis.
• Previous history of ipsilateral breast surgery and impaired cosmetic outcome,
as assessed by the treating surgeon or radiation-oncologist
• Extensive DCIS component.
• Invasive lobular carcinoma.
• MRI absolute contraindications as defined by the Radiology Department.
• Multicentricity or multifocality on MRI.
• Nodal or other organ involvement with cytological or histological
confirmation.
• Treatment with neo-adjuvant chemo- and immunotherapy. .
• Indication adjuvant chemo- and immunotherapy (endocrine treatment is
allowed).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective is to evaluate the pathologic complete response rates<br /><br>following single dose ablative partial breast radiotherapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>• Rate of radiological response on MRI.<br /><br>• Quality of life assessment.<br /><br>• Acute- and late-toxicity assessment.<br /><br>• Cosmetic outcome assessment.<br /><br>• Frailty assessment in study population<br /><br>• Local -, regional - and distant relapse rates.<br /><br>• Disease free - and overall survival rates.<br /><br><br /><br>Tertiary endpoint:<br /><br>• Future research on radiotherapy- associated genotyping.</p><br>